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HER2 Positive Metastatic Breast CancerPhase 2NCT04681287

Exploratory Study of Advanced Breast Cancer in HER2 Positive Patients With Failure of Multi-line Therapy Treated by Combination of Inetetamab (Cipterbin) + PD-1 Inhibitor Combined With Utidelone.

A Phase 2 study testing inetetamab and PD-1 inhibitor combined with chemotherapy. in people with HER2 Positive Metastatic Breast Cancer, run by Henan Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study plans to explore the efficacy and safety of chemotherapy combined with inetetamab and PD-1 inhibitors in HER2 positive advanced breast cancer who failed to receive trastuzumab and TKIs, and explore the dominant population of dual antibody combination to further guide the precise and individualized treatment… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
HER2 Positive Metastatic Breast Cancer
What is being tested?
inetetamab and PD-1 inhibitor combined with chemotherapy.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
23 Apr 2021to 30 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18-75 years old female patients;
  • The results showed that HER-2 was positive at least once in patients with recurrent and metastatic breast cancer confirmed by pathology: HER-2 (+ + +) was confirmed by immunohistochemistry; if HER-2 (+ +), fish / CISH was required to confirm HER-2 amplification;
  • Previous treatment (including neoadjuvant, adjuvant and rescue therapy) received at least trastuzumab and TKIs;
  • It is allowed that the previous rescue chemotherapy does not exceed 3 lines, and must be disease progression before being included in the study; it is allowed to receive rescue endocrine therapy; chemotherapy allows to receive one of the chemotherapy of albumin binding paclitaxel, vinorelbine, gemcitabine, capecitabine and aribrin;
  • At least one target lesion can be defined according to RECIST 1.1, and the target lesion has not received radiotherapy (or other local treatment), unless it progresses after the treatment;
  • Before the study, chemotherapy and targeted therapy must be completed for at least 2 weeks, and endocrine therapy and antiangiogenic drug treatment for 1 week;
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  • ECoG PS: 0-1 points;
  • The expected survival time was more than 3 months;
  • The function of the main organs is normal, that is to say, it meets the following standards:
  • 1）Blood routine examination standard should meet (no blood transfusion and blood products within 14 days, not used G-CSF and other hematopoietic stimulating factors were corrected)
  • Hb≥90g/L；
  • ②ANC≥1.5×109/L；
  • ③PLT≥75×109/L； 2）Biochemical examination should meet the following standards:
  • TBIL<1.5×ULN；
  • Alt, AST < 2.5 × ULN, liver metastasis < 5 × ULN;
  • Bun and Cr ≤ 1 × ULN or creatinine clearance rate ≥ 50ml / min (Cockcroft Gault formula).
  • 10.Women of childbearing age must have a pregnancy test (serum) within 7 days before enrollment, and the results are negative, and they are willing to use appropriate contraceptive methods during the trial and within 8 weeks after the last administration of the trial drug; 11.The subjects volunteered to join the study, signed the informed consent form, had good compliance and cooperated with the follow-up.

Who cannot join

  • Symptomatic, uncontrolled brain metastases or leptomeningeal metastases.However, patients with stable condition after local treatment for 4 weeks could be enrolled;
  • There was effusion in the third space which could not be controlled by drainage or air pressure;
  • Interstitial lung disease, non-infectious pneumonia, memory pneumonia, pulmonary fibrosis and other diseases;
  • Those who have a history of live attenuated vaccine vaccination in the 28 days before the first study medication or are expected to receive live attenuated vaccine in the study;
  • Other malignant tumors in the past 3 years, excluding cervical carcinoma in situ, basal cell carcinoma of skin or squamous cell carcinoma of skin;
  • Patients with hypertension who could not be reduced to normal range after antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);
  • Suffering from serious or uncontrollable diseases, including but not limited to:
  • 1) Active viral infection, such as HIV, HBV active phase (HBsAg positive and HBV-DNA ≥ 103, hepatitis C antibody positive); 2) Previous severe cardiovascular diseases: uncontrollable hypertension; myocardial infarction, unstable arrhythmia, congestive heart failure, pericarditis, myocarditis, etc. in the first six and six patients; according to NYHA standard, grade III ~ IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) < 50% according to NYHA standard; 8.Patients with a history of psychotropic substance abuse and unable to quit or with mental disorders; 9.According to the judgment of the researchers, there are other patients with accompanying diseases that seriously endanger the safety of patients or affect patients to complete the study; 10.Pregnant or lactating women; 11.The researchers think it is not suitable for the participants.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Henan cancer hospital

    Zhengzhou, Henan, 450008

Other trials in China

About this study

This study plans to explore the efficacy and safety of chemotherapy combined with inetetamab and PD-1 inhibitors in HER2 positive advanced breast cancer who failed to receive trastuzumab and TKIs, and explore the dominant population of dual antibody combination to further guide the precise and individualized treatment of advanced HER2 positive breast cancer.

Being tested
inetetamab and PD-1 inhibitor combined with chemotherapy.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • inetetamab and PD-1 inhibitor combined with chemotherapy.Drug

    1. Chemotherapy selected by doctors: albumin bound paclitaxel, vinorelbine, gemcitabine, capecitabine, and aribrin were administered according to clinical routine;
    2. The first dose was 8 mg / kg, followed by 6 mg / kg, once every 3 weeks
    3. PD-1 inhibitor 200mg D1 every 3 weeks as a cycle Treatment to disease progression or toxicity intolerance, or death from any cause.

    The efficacy was evaluated every 2 cycles and adverse events were recorded. After 4-6 cycles of treatment, if the patient is intolerable to chemotherapy for any reason, the chemotherapy can be stopped and the combination of inistumab and PD-1 can be continued.

Study groups in NCT04681287
Study groupRoleWhat they receive
inetetamab and PD-1 inhibitor combined with chemotherapy.ExperimentalNot described
Receives: Drug: inetetamab and PD-1 inhibitor combined with chemotherapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression-free survival rate at 3 months（PFS rate）

    The rate of events from date of randomization until observation of disease progression or death from any cause at 3 months

    Measured: Estimated up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2020
  2. Study start23 Apr 2021
  3. Primary completion4 Nov 2021
  4. Study completion30 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Patients with advanced HER2 positive breast cancer who had received at least paclitaxel, trastuzumab and TKIs (lapatinib or Pyrotinib) at least in the past were included in this study,Efficacy and safety of combination of inetetamab and PD-1 inhibitor combined with chemotherapy (including albumin bound paclitaxel, vinorelbine, gemcitabine, capecitabine or aribrin).
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04681287
Sponsor's protocol ID
HNCH-HER2-MBC001
Status last verified
Sep 2023
First submitted
18 Dec 2020
Last updated
25 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lv H, Sun T, Ling X, Liu X, Yang J, Zhang M, Niu L, Chen S, Liu Z, Wang C, Sun H, Wang J, Zeng H, Zhao S, Guo L, Feng Y, Zhang Z, Xia Q, Qiu R, Yan M. Inetetamab plus camrelizumab and utidelone for pretreated HER2-positive advanced breast cancer: a prospective, single-arm, phase 2 study. BMC Med. 2026 Jan 27;24(1):108. doi: 10.1186/s12916-026-04643-z.

    PubMed 41593669

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing inetetamab and PD-1 inhibitor combined with chemotherapy. in people with HER2 Positive Metastatic Breast Cancer, run by Henan Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival rate at 3 months（PFS rate） (time frame: Estimated up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04681287, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.

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